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Low-dose Cyclophosphamide or CNI in the Prevention of Acute Graft-versus-host Disease After gDLI

NCT06490562 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-07-08

No results posted yet for this study

Summary

Assess the cumulative incidence of severe (III-IV) aGVHD after low-dose cyclophosphamide or CNI is used to after gDLI. Evaluate the overall survival rate (OS), non recurrent mortality rate (NRM), and recurrence rate (CIR) of two groups of patients; The complete response rate (CR) and partial response rate (PR) of patients with morphological/extramedullary recurrence, as well as the complete response rate and MRD response rate of patients with molecular recurrence. The incidence of adverse events such as infection, hemorrhagic cystitis, and cardiac events in two groups.

Conditions

  • Acute Graft-versus-host Disease

Interventions

DRUG

PDCy

Low dose Cy 30 mg/kg/d was administered on the 3rd and 4th day after gDLI to prevent GVHD

DRUG

Non Cy

Oral administration of low-dose CNI (CSA 25mg Q12H or FK506 0.25mg Q12H combined with azole fungal drugs) for 2 weeks to prevent GVHD at 0 days after gDLI

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2028-05-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06490562 on ClinicalTrials.gov